MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-01-11 for ADCON-L ANTI-ADHESION BARRIER GEL G0024 manufactured by Gliatech Medical, Inc..
[20509327]
On 12/01 the quality department at gliatech received a copy of a publication entitled, "results of applying adcon-l gel after lumbar discectomy" the german adcon-l study. " (h. P. Richter et al, 2001). In the study involving 357 evaluable patients (180 adcon-l;177 control group) the authors "found no positive effect of treatment with adcon-l gel in patients in whom one-level lumbar microdiscectomy was performed. " the study also included a safety analysis (based on all 398 patients recruited). Of the noted adverse events in the adcon-l group, "one patient had spondylodiscitis, one patient an allergic reaction and itching of the legs, and one patient suffered joint pain. In the control group, one patient had spondylodiscitis, one patient underwent an abdominal operation because of adhesion, and one patient experienced postoperative fever. " the authors also noted that 10 patients underwent reoperation (6 adcon-l;4 control). The authors noted that, "in terms of safety analysis, in summary, there was no remarkable difference in the incidence of adverse events or reoperation" and "there is no indication, based on company's results, that treatment with adcon-l causes an adverse reaction. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00001 |
| MDR Report Key | 372149 |
| Report Source | 05 |
| Date Received | 2002-01-11 |
| Date of Report | 2002-01-11 |
| Date of Event | 1996-11-14 |
| Date Mfgr Received | 2001-12-12 |
| Date Added to Maude | 2002-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 23420 COMMERCE PARK ROAD |
| Manufacturer City | CLEVELAND OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168313200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADCON-L ANTI-ADHESION BARRIER GEL |
| Generic Name | INHIBITOR, PERIDURAL |
| Product Code | MLQ |
| Date Received | 2002-01-11 |
| Model Number | NA |
| Catalog Number | G0024 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 361282 |
| Manufacturer | GLIATECH MEDICAL, INC. |
| Manufacturer Address | 23420 COMMERCE PARK RD. CLEVELAND OH 44122 US |
| Baseline Brand Name | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
| Baseline Generic Name | INHIBITOR, PERIDURAL FIBROSIS |
| Baseline Model No | NA |
| Baseline Catalog No | G0024 |
| Baseline ID | 5 GRAMS IN SYRI |
| Baseline Device Family | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-01-11 |